A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Embolism; Thrombosis; Cancer

Treatments: Drug: Apixaban; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00320255

CV185-027

Details and patient eligibility

About

The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.

Enrollment: 130 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
• Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
• Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
• Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law

Key Exclusion Criteria:

• Women who are pregnant, breastfeeding
• History of deep vein thrombosis or pulmonary embolism
• Active bleeding or at high risk of bleeding
• Metastatic brain cancer
• Familial bleeding diathesis
• Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
• Expected survival <6 months or an Eastern Cooperative Oncology Group performance status ≥3.
• Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
• Uncontrolled hypertension (systolic blood pressure >200 mm Hg and/or diastolic blood pressure >110 mm Hg
• Coagulopathy (international normalized ratio >1.5 or platelet count <100*10^9/L) if not yet receiving chemotherapy or <50*10^9/L if receiving chemotherapy). Platelet count must have been >100*10^9/L before starting study medication
• One or more of the following: alanine aminotransferase >3 times the upper limit of normal (ULN), total bilirubin >2*ULN, or calculated creatinine clearance <30 mL/min.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 6 patient groups, including a placebo group

Cohort 1: Placebo

Placebo Comparator group

Description:

Participants received placebo tablets once daily

Treatment:

Drug: Placebo

Cohort 1: Apixaban, 5 mg

Placebo Comparator group

Description:

Participants received apixaban as tablet, 5 mg, once daily

Treatment:

Drug: Apixaban

Cohort 1: Apixaban, 10 mg

Active Comparator group

Description:

Participants received apixaban as tablet, 10 mg, once daily

Treatment:

Drug: Apixaban

Cohort 1: Apixaban, 20 mg

Active Comparator group

Description:

Participants received apixaban as tablet, 20 mg, once daily

Treatment:

Drug: Apixaban

Cohort 2: Placebo

Placebo Comparator group

Description:

Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.

Treatment:

Drug: Placebo

Cohort 2: Apixaban, 5 mg

Active Comparator group

Description:

Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.

Treatment:

Drug: Apixaban